Sample size for Clinical endpoint BE studies [Software]
Hi Kotu,
Both are fine. However, considering the subject line none (!) of them support sample size estimation for BE studies with reference-scaling. There is no explicit formula for power. Hence, Monte-Carlo simulations are required. You have essentially two options:
No idea. Be aware that the final responsibility concerning validation of software lies in your hands.
❝ 1. PASS
❝ 2. nQuery Advisor+ nTerim.
Both are fine. However, considering the subject line none (!) of them support sample size estimation for BE studies with reference-scaling. There is no explicit formula for power. Hence, Monte-Carlo simulations are required. You have essentially two options:
- Use the package
PowerTOST
for R. This is what the authors of the sample size tables* recommend.
- Code simulations in your software of choice.
SAS
is terribly slow (roughly by a factor of 1,000 compared toPowerTOST
), MatLab is a little bit faster. I guess thatC
could perform similar toPowerTOST
.
❝ Which soft ware is more reliable for regulatory agencies to construction of Sample size calculation for Clinical trials?
No idea. Be aware that the final responsibility concerning validation of software lies in your hands.
PowerTOST
contains sample size tables from the literature and test-scripts to support you in this task.- Endrényi L, Tóthfalusi L. Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs. J Pharm Pharmaceut Sci. 2011;15(1):73–84. online
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Sample size for Clinical endpoint BE studies balakotu 2015-12-15 12:28 [Software]
- Sample size for Clinical endpoint BE studiesHelmut 2015-12-15 12:54
- Sample size for Clinical endpoint BE studies Dr Ripal 2015-12-29 12:12
- Sample size for Clinical endpoint BE studies Helmut 2015-12-29 13:29
- Sample size for Clinical endpoint BE studies Dr Ripal 2015-12-29 12:12
- Sample size for Clinical endpoint BE studiesHelmut 2015-12-15 12:54